Sr CRA - Netherlands
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical clinical trials.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Pharmaceutical clinical research / Clinical Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
risk-based monitoring, root cause analysis, critical thinking, problem-solving, data accuracy verification, physical inventory management, regulatory compliance knowledge, audit readiness, stakeholder management, reporting
Preferred skills
experience with FSO/FSP/Government monitoring environments, knowledge of ICH-GCP guidelines, ability to manage multiple sites
Technologies
SDR, SDV, CRF
Responsibilities
Monitor investigator sites using a risk-based approach to identify failures and implement corrective actions; Ensure data accuracy through source data review and CRF assessment; Assess investigational product via physical inventory and records review; Document observations and deficiencies in reports; Escalate and resolve issues with clinical management; Maintain regular contact with investigative sites to confirm protocol adherence; Participate in investigator payment processes; Provide trial status tracking and progress reports to the Clinical Team Manager.
